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Class 1 Medical Devices

As per European Medical Device Regulation (MDR) Class I medical devices present minimal potential for harm to the user and are often simpler in design than Class 1s, Class 1m, Class IIa, Class IIb or Class III Medical Devices. Most Class I medical devices can be self Certified by EU MDR or even as per US FDA regulations.

Class 1 device CE marking, Notified Body involvement is not mandatory. Class 1 products manufactures ISO 13485 implementation and certification is not required. Minimum level of GMP compliance is recommended. In short, some controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device is required.

Class 1 devices are again divided into two:

All class 1 devices can affix CE Mark by self declaration. The manufacturer is responsible for ensuring that his product complies with all the relevant Essential Requirements of the Directive and must complete the Essential requirement Check list.

We support class 1 Medical Device manufactures with the following Services

(a) Guidance & Technical File

(b) Arrange Certificate of Compliance from and European Third Party.

(C) Arrange EU Representative from Europe

(d) Arrange Free Sale Certificate from Europe.

More details about process of certification click here .

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